Public Release: 

Ovarian cancer cells killed by new drug

The European Society for Medical Oncology (ESMO)

European Society for Medical Oncology

NOT FOR RELEASE BEFORE 12.00 BST, FRIDAY, 20 JUNE 2003

Doctors in Europe are hopeful that a new drug, which acts in a different way from other drugs, will be effective for ovarian cancer. The drug, known as ET743, has been given to 50 patients with advanced ovarian cancer and preliminary results of the trial conducted by the Southern Europe New Drug Organisation (SENDO), were presented at the European Society for Medical Oncology conference in Edinburgh today (20 June).

"ET743 has a unique mechanism of killing tumour cells sometimes even when established drugs have failed," said Dr Gabriella Parma from the European Institute of Oncology in Milan. In the trial, the patients were divided into two groups. All the women had been previously treated with other anticancer drugs, namely cisplatin and taxanes, and later developed progressive cancer. The first group had ovarian cancer that had never responded to therapy. The other group of women had been treated successfully but had relapsed after six months. All the women received an infusion of ET743 every three weeks for at least two months. Once the dose had been stabilised, the treatment appeared to be well-tolerated without the risk of serious side-effects.

"We found that the tumour decreased in some of the patients including one patient who had not previously responded to prior therapies. We are encouraged by these results," said Dr Parma. These results have been reviewed and confirmed by an independent panel of experts.

Further studies are needed to understand if these encouraging results translate into an improvement in survival in these cancer patients. Because the drugs work in different ways, Dr Parma and her team are now investigating combining ET-743 with cisplatin or taxol.

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Notes to Editors
About the European Society for Medical Oncology (ESMO)
ESMO believes that every cancer patient is entitled to the best possible treatment available. Since medicine is involved in every aspect of cancer therapy, cancer patients need to be treated by qualified medical oncologists. ESMO is the leading European Society that provides education and guidelines for medical oncologists to ensure optimal care for cancer patients. Its official scientific journal is Annals of Oncology. Since 1975, the Society has grown to include representatives from every European country and the six major geographical regions of the world. More information about the Society can be obtained at www.esmo.org.

The ESMO Summer Educational Conference (ESEC) takes place in Edinburgh, Scotland, UK - 19 - 22 June 2003.

Abstract 50PD- Discussion Time: 10.00-10.45, Sunday, 22 June 2003, Fintry Suite

YondelisTM (ET743, trabectedin) antitumor activity in ovarian cancer patients pretreated with platinum-taxane regimens

Gabriella Parma (1,2), Jean Bauer (1,3), Cristina Noberasco (1,2), Antonella Perotti (1,4), Miguel Izquierdo (5), J. Jimeno (5), Silvia Marsoni (1), Nicoletta Colombo (1,2), Giuseppe Capri (1,4), Cristiana Sessa (1,6)

(1) SENDO - Southern Europe New Drug Organization, Milano, Italy (2) Istituto Europeo di Oncologia, Milano, Italy (3) Centre Pluridisciplinaire Oncologie, Lausanne, Switzerland (4) Istituto Nazionale Tumori Milano, Milano, Italy (5) PharmaMar S.A., Madrid, Spain (6) Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland

ET743 is a marine compound with a unique mechanism of action. The striking activity in ovarian cancer cell lines and xenografts prompted the Ph II clinical trial of ET-743 in advanced ovarian cancer (AOC) patients (pts) refractory (RF, progressing while on or within 6 mos. from 1st line therapy) to or relapsing (RP, relapsing after more than 6 mos.) after platinum-taxane therapy. ET-743 was given as a 3-hr infusion q3 weeks with steroids and 5HT3 antagonists as antiemetic prophylaxis. The initial dose of 1650 ìg/m2 (N=6) was decreased to 1500 ìg/m2 (N= 12) because of 100% grade 3-4 asthenia at cy 1 and then to 1300 ìg/m2 (N= 28) because of early reversible increase in transaminases. As per 2/03 46 pts entered the study and 36 are evaluable for response according to RECIST criteria; 1 partial objective response was reported in 19 RF pts (5%) while 8 responses (1 CR, 7 PR) occurred in 17 RP pts (47%, 95% CI: 23%-72%). The main toxicities were dose-related asthenia, N&V and increased transaminases; neutropenia was mild and the dose of 1300 ìg/m2 could be maintained in about 80% of pts . Conclusions: at 1300 ìg/m2 ET-743 is active and well tolerated in RP AOC pts after platinum-taxane. The synergistic effect observed in preclinical models and the promising clinical results as second line therapy prompted the evaluation of ET-743 in combination with cisplatin or doxorubicin as regimens of potential interest in AOC.

Gabriella Maria Parma

Curriculum Vitae

Education 1991-1995: Specialty School in Obstetrics and Gynecology, University of Milano.

1996-1999: PhD Thesis on Oncological Science in Gynecology.

Qualifications 1991: Medicine Degree.

1995: Board certification in Obstetrics and Gynecology.

2000: PhD Board certification

Internships 1990-1991 Undergraduate training - Dept of Obstetrics and Gynecology - S. Gerardo Hospital - Monza - University of Milano.

1991-1995 Postgraduate training - Dept of Obstetrics and Gynecology - H.S.Gerardo-Monza - University of Milano

1996-1999 Fellowship - Dept of Gynecology - EIO - Milano.

Stage Dept of Medical Oncology (Director Prof. F. Cavalli) - S. Giovanni Hospital - Bellinzona - Swizterland

Dept of Obstetrics and Gynecology (Director K. Hatc) - University Hospital - Tucson - Arizona - USA

Current position Senior Assistant at Dept of Gynecology - EIO - Milano

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